FDA hearings discuss risk communication tools

The FDA conducted two days of public hearings this week aimed at examining the tools used by the agency to alert doctors and patients about risks associated with prescription drugs."In the past year we have made significant strides in alerting healthcare professionals and their patients of emerging risks associated with prescription medications," said acting FDA commissioner Andrew von Eschenbach in a statement. "We intend to use the public feedback we receive at this meeting to advance our understanding of the effectiveness of our current efforts and to develop new tools to hone our ability to inform the public." The FDA said it would pose six questions to gather information about which communication tools are effective and how risk communications can be improved. These tools include patient information sheets, healthcare professional information sheets, public health advisories, press releases, the MedWatch Listserv information sheets, Patient Safety News, CDER educational campaigns and the CDER Web site.In a statement, the agency explained it is working to devise a "modern system" for communicating drug safety information to aid in the evaluation of the benefits and risks of taking prescription medicines, ultimately leading to more informed prescribing and treatment decisions.Other topics of discussion included potential reformatting of the FDA's Web site and the possibility of creating uniform patient labeling.

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